Manager, Analytical Quality Lab

3 weeks ago

Racine, Wisconsin, United States Merz North America Inc Full time

About the Company:

Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.

Key Responsibilities:

Supervision/Coordination:

  • Manage staff including interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  • Independently set clear direction for all direct reports consistent with departmental needs.

Quality Testing:

  • Evaluate and implement new analytical technologies per Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed.
  • Ensure completion of all testing, including raw materials, in-process, final release, stability, environmental, biological, and special project/protocol testing in a timely manner that achieves fulfillment to commitments.
  • Ensure lab investigations are timely and in compliance with current regulatory standards and expectations

Support Manufacturing:

  • Serve as a resource for manufacturing to determine best course of action and material dispositions for investigations and unexpected occurrences.

Quality System Support:

  • Lead investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement.
  • Identify and implement new quality improvement initiatives / projects in accordance with cGMP / cGLP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies.
  • Work with manufacturing and other functional groups on manufacturing regulatory compliance issues.
  • Lead training program by developing, coordinating, and delivering assigned training tasks.
  • Serve as a liaison with the Quality, Operations, Commercial, and Project Team members.
  • Update and communicate all needed issues as appropriate to facilitate understanding and rapid decision-making.
  • Participate in product development and technical transfer teams as a subject matter expert on testing and quality matters.

Audit Support:

  • Participate in external audits as a subject matter expert on test method, test method validation, and test method development.

Quality Assurance:

  • Perform internal and vendor quality system audits.
  • Perform routine walk-throughs and compliance checks to verify adherence to quality guidelines. Interact with inspectors in regulatory audits to represent area of responsibility.

Budgeting:

  • Adhere to established expenditure controls to support management of laboratory budget.

Education:

  • BS in Physical Science or related field. Required
  • Advanced degree (MS, PhD, etc.) in a physical science field. Preferred

Experience:

  • GLP/GMP experience. Required
  • At least 5 years' experience Pharmaceutical or Medical Device Laboratory. Required
  • Supervision/leadership experience. Preferred

Knowledge, Skills and Abilities:

  • Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines. Required
  • Quality experience may include quality testing (analytical chemistry/microbiology), QA/Regulatory, or Validation. Required
  • Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information. Required
  • Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution. Required

Must be able to pass vision testing requirements (with or without corrective eyewear).

- 20/20 Near Acuity Vision

Benefits:

  • Comprehensive Medical, Dental, and Vision plans
  • 20 days of Paid Time Off
  • 15 paid holidays
  • Paid Sick Leave
  • 401(k)
  • And more

Your benefits and PTO start the date you're hired with no waiting period
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c) Quality

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